Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole

NCT01509053 | Terminated Phase 3 Results

• 1 other identifier: 31-11-284
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 10

Brief Summary

The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Comparison of Inpatient Psychiatric Hospitalization Rates

  The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.

  Retrospective period Months 4-6; Prospective period Months 4-6

Secondary Outcomes (4)

• Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score

  Baseline, Week 24

• Change From Baseline in PANSS Positive and Negative Subscale Scores

  Baseline, Week 24

• Clinical Global Impression of Severity (CGI-S) Score

  Baseline, Week 24

• Clinical Global Impression of Improvement (CGI-I) Score

  Baseline, Week 24

Study Arms (1)

Aripiprazole IM depot injection

EXPERIMENTAL

Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase. Oral aripiprazole was available as rescue medication if necessary.

Drug: Aripiprazole (Abilify®) IM Depot Injection; Drug: Oral aripiprazole

Interventions

Aripiprazole (Abilify®) IM Depot Injection DRUG

400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg. Number of injections: 6. Participants have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2014.

Also known as: ABILIFY®

Aripiprazole IM depot injection

Oral aripiprazole DRUG

Oral aripiprazole tablets 10-15 mg/day (up to 30 mg/day).

Aripiprazole IM depot injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to any protocol-required procedure.
• Male and female subjects 18 to 65 years of age, inclusive
• Current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and a history of the illness for at least 1 year (12 months)
• Subjects who in the investigator's judgment would benefit from extended treatment with a long-acting injectable formulation
• Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24 months) prior to screening, but have been managed as outpatients for the 4 weeks prior entering the study
• Subjects must have been on oral antipsychotic treatment for the full 7 months prior to the screening phase Subjects who have shown response to previous antipsychotic treatment.
• Subjects who understand the nature of the trial and are able to follow the protocol requirements.

You may not qualify if:

• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months for any reason must not be enrolled into this trial.
• Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial.
• Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication.
• Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
• Subjects with a history of hypersensitivity to antipsychotic agents.
• Subjects deemed intolerant of receiving injectable treatment.
• Subjects who have received electroconvulsive therapy within the last 7 months prior to screening.
• Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
• Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
• Subjects requiring hospitalization for any psychiatric reason during the 4 weeks prior to signing the Informed Consent Form (ICF) or during the screening period.
• Subjects without at least 1 inpatient psychiatric hospitalization in the last 2 years (24 months) prior to screening.
• Subjects who have met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening.
• Subjects who are considered treatment-resistant to antipsychotic medication other than clozapine.
• Treatment with long-acting injectable antipsychotics in which the last dose was within 7 months prior to screening.
• Subjects who have not been treated with oral antipsychotics for 7 months prior to screening.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (10)

Unknown Facility

Bruges, 8310, Belgium

Location

Unknown Facility

Brussels, 1160, Belgium

Location

Unknown Facility

Kortenberg, 3070, Belgium

Location

Unknown Facility

Liège, 4000, Belgium

Location

Unknown Facility

Lovech, 5500, Bulgaria

Location

Unknown Facility

Novi Iskar, 1282, Bulgaria

Location

Unknown Facility

Pazardzhik, 4400, Bulgaria

Location

Unknown Facility

Tzerova Koria, 5047, Bulgaria

Location

Unknown Facility

Penticton, British Columbia, V2A 4M4, Canada

Location

Unknown Facility

Chatham, Ontario, N7M 5L9, Canada

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Affairs
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

800-562-3974

Study Officials

• Tim Peters-Strickland

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 4, 2015
• Results First Posted: January 16, 2014

Record last verified: 2015-02

Locations

BE (4); BU (4); CA (2)